Politics often supersedes medical science as the determining factor behind the
Food and Drug Administration's granting or denying of approval of prescription
drugs. This is the result of a long-term trend that has come sharply into
focus with the FDA's handling of the diabetes drug Avandia.

Three years ago, a political and public relations campaign began to drive
Avandia from the market. It was not prompted by the findings of any particular
clinical trial but on the "meta-analysis" of many small, short-term trials.
The method of such analysis was to selectively isolate data from these trials
and combine apples and oranges developed under varying criteria and controls
to form a "meta-conclusion" not reached by the scientists who conducted any of
the actual trials. Anyone can now replace lengthy and expensive clinical
trials with a Web browser, a pocket calculator and a press conference to
announce their conclusions.

This "research" was not rushed to the FDA to alert physicians. Instead it was
given to the majority staff of the House Committee on Oversight and Government
Reform for the purpose of "discussing pending legislation." The chairman of
that committee immediately issued a press release evaluating the meta-analysis
and calling it "a case study of the need for reform of the nation's drug
safety laws."

Was this press release based on then-Chairman Henry Waxman's vast clinical
experience? Or was his press release itself a case study of how to distort,
manipulate and manufacture research data to support a political agenda?

The study was later given to a prestigious medical journal for publication.
That was delayed so the publication could first write an editorial using the
study in pursuit of its political agenda -- hostility toward firms developing
new pharmaceuticals.

About the time the study was finally sent to the FDA, a national publicity
campaign included the author of the analysis proclaiming, on ABC news and
other media, that "the deaths caused by Avandia could dwarf the carnage of
September 11, 2001." So much for professional, dispassionate clinical analysis
-- which is not very effective in frightening the general public or
encouraging litigation.

In spite of this aggressive public relations campaign, in 2007 the
Endocrinology and Metabolic Drug Safety and Risk Management Advisory
Committees of the FDA found (by a large majority) no reason to remove the drug
from the market. One of the testifying FDA department heads urged that
Avandia be removed immediately because it had not been proven to reduce heart
attacks. He expressed no concern for the millions of patients benefiting from
the drug's ability to prevent kidney failure, amputation of extremities and
loss of vision.

In 2010 the ritual was repeated with more dubious analysis of clinical
trials by people who did not conduct them. This time the campaign was first
taken to the staff of the Senate Finance Committee, who faithfully reported to
their chairman and ranking member what they wanted to hear. The public, on
this occasion, was treated to the mature medical and clinical judgment of
Senator Grassley on national network television.

The FDA Advisory Committee once again refused to recommend withdrawal of the
drug, in favor of more cautionary labeling.

However, a major influence had come into play since 2007: political
appointments by President Obama to the highest levels of the FDA, which
overruled the recommendations of the physicians on the Advisory Committee.

After use of Avandia for years by millions of patients, objective evaluation
of its long-term effectiveness and safety has been taken out of the hands of
physicians. Instead we must rely on the verdict of politicians.

Medical decisions by agents of government, like the FDA, inevitably and
necessarily become political decisions. We cannot remove the politicians from
these decisions without first removing the FDA.